Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Ant Hi-Tech Industrial Co., Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131770 | PRESSURE CONNECTING TUBE | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2014-02-26 | 254 | 0 |
| K102648 | ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2011-07-01 | 290 | 0 |
| K091408 | DISPOSABLE PRESSURE TRANSDUCER | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2009-08-18 | 98 | 0 |
| K072696 | ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,20 | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2008-05-02 | 221 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda